FDA Wide Scientific Services_final DRAFT 10 12 2022.docx 12 20 pm.pdf

Statement of Work

FDA Scientific Services U.S. Food and Drug Administration

DRAFT

10-12-2022

Table of Contents

1. INTRODUCTION

1.1 Background

1.2 Objectives

2. SCOPE

3. TASK AREAS

3.1 Research and Technical Guidance

3.2 Scientific Consultation (IT and Information Management Systems)

3.3 Scientific Investigations, Procedures and Analysis

3.4 Publishing

3.5 Laboratory Technical and Administrative Support

3.6 Task Management

Process and Procedure Improvement

Transition

4. DELIVERABLES

5. OTHER REQUIREMENTS

6. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

7. CONTRACTING OFFICER (CO)

8. HOURS OF OPERATION

9. PERIOD OF PERFORMANCE

10. PLACE OF PERFORMANCE

11. GOVERNMENT FURNISHED EQUIPMENT (GPE)/ GOVERNMENT FURNISHED

INFORMATION (GPI)

12. KEY PERSONNEL

13. INVOICE SUBMISSION

14. CONTRACTOR PERFORMANCE ASSESSMENT REPORT

15. SECURITY REQUIREMENTS

16. SUPPORT for Capital Planning and Investment Control

17. CLAUSES

Appendix 1: Labor Categories and Descriptions ………………………………………………………. 26

1. INTRODUCTION

1.1 Background

The Food and Drug Administration (FDA) is a science-based regulatory agency critically important to the stability of the nation’s public health and health care systems. FDA protects and promotes the health and safety of all Americans by enhancing the availability of safe medical products and foods and promoting innovation that addresses unmet medical and public health needs. FDA also protects and promotes the health and safety of animals by assuring the availability of safe animal drug products and food. FDA decisions must be based on the best available scientific data and use the best tools and methods available to ensure products meet the highest quality standards for consumers, while fostering and advancing innovation in the products it regulates.

In support of its regulatory mission, FDA conducts scientific research concerning vaccines, blood products, drug safety, food and food safety, food and color additive review, micro-analytical evaluations, cosmetics, colors certification, veterinary medicine, tobacco products, toxicology, medical devices, and radiological products as well as method development and method validation for regulatory laboratories and other scientific research. It also supports new technologies (such as genomics and proteomics) with traditional toxicological data, and it analyzes and visualizes these data to formulate new regulatory standards. Individual FDA Centers often leverage their resources by conducting integrated research programs with other FDA Centers and Offices and through collaborative agreements with government agencies, academia, and industry.

More so than ever before, FDA’s science is data-centric, complex, and collaborative, involving multidisciplinary groups. FDA researchers and other scientists must have access to the latest documented advancements across the medical disciplines, as well as leverage IT and information managements systems to knowledge-share policies, procedures, and data in their fields of expertise.

The purpose of this Scientific Services IDIQ contract is to enable all FDA Centers to have access to an experienced set of scientific professionals who will apply best practices and innovative processes and solutions effectively across centers and offices.

1.2 Objectives

The scientific services will support each Center’s mission with increased accuracy on findings, supported data analysis and timely reporting.

The scientific services will represent industry best practices shared across all offices, divisions and branches located within the structure of the FDA to achieve improvement and advancement in scientific processes and procedures.

2. SCOPE

The following scientific-related professional services will be available across all FDA Centers:

Research and technical guidance related to policy across medical disciplines;

Consulting regarding improvements to IT and information management systems in support of scientific processes and activities;

Scientific investigations, procedures, plans, clinical data analysis and reporting;

Drafting of scientific documentation suitable for public dissemination;

Laboratory technical and administrative support; and

Task management directly and specifically focused on the scientific requirements at the Task Order level.

The scope does not include procurement of IT hardware.

Specific details for the work will be defined and provided in each Task Order issued under this

IDIQ.

3. TASK AREAS

Independently, and not as an agent of the Government, the Contractor shall perform tasks that provide scientific-related professional services for the FDA. The task areas to be performed under this IDIQ are listed directly below. The labor categories to be applied to the task areas are detailed in Appendix 1.

3.1 Research and Technical Guidance

The Contractor shall provide scientific research support that will inform or result in technical guidance and expertise related to regulatory, pharmaceutical, public health and manufacturing functions across the FDA Centers. Examples include, but are not limited to, research areas that address emerging technologies (e.g. continuous manufacturing, 3D printing, nanotechnology, biosimilars, and biologics).

3.2 Scientific Consultation (IT and Information Management Systems)

The Contractor shall provide research information, consultation, technical and functional analysis that will assist the FDA with decisions on procurements of hardware and software that can be used to advance scientific-related processes, procedures and workflows. The Contractor shall provide technical support to successfully transfer operational databases, models, methods, or tools developed on Contractor platforms to FDA internal platforms, including full documentation and code.

The Contractor shall identify functional gaps and efficiencies and participate and coordinate with the Office of Information Management and Technology (OIMT) on design plans for hardware (such as networking, data storage and computing resources) and software solutions to meet the needs of laboratory and other science activities. The Contractor shall maintain the general scientific IT knowledge management infrastructure (e.g., SharePoint scientific content) and manage the inventory of scientific software licenses for designated offices.

3.3 Scientific Investigations, Procedures and Analysis

The Contractor shall provide support for scientific investigations on evaluating the feasibility and capability for various regulatory policies and actions including Standard Operating Procedures (SOPs), Manuals of Policy and Procedures (MAPPs), and Guidance for FDA-agency level, and Center/Office products. Contractor investigations shall include data collection, database development and management, analysis (e.g., computational experiments/research, meta-analysis), method development, critical reviews, technical surveys of industry capability and technology gaps that are not currently addressed by policies and actions (e.g., emerging technology guidance).

Scientific investigations may also involve the surveillance and testing of pre- and post-market drugs and drug products as it relates to current world events.

The Contractor shall review and edit clinical data plans, conduct data collections, perform data analysis, and write assessment reports that may address data quality, sufficiency, and integrity.

3.4 Publishing

The Contractor shall submit material to the Government for consideration to publish or present health research/consultation related to drug shortages and access due to quality and manufacturing, and public health emergencies due to drug quality, surveillance and manufacturing processes that may have negative impacts on public health.

3.5 Laboratory Technical and Administrative Support

The Contractor shall provide support to assist, operate, maintain, calibrate, and repair various laboratory systems, instrumentation, and equipment. Examples include but are not limited to benchtop bioreactor systems, cell and biochemical analyzer systems, bio-layer interferometer, and protein purification systems. Additionally, the Contractor shall assist with the upkeep of inventory of lab supplies, sample-collection, -management and -analysis, data analysis and other laboratory project specific support tasks.

3.6 Task Management

The Contractor shall provide both Indefinite Delivery, Indefinite Quantity (IDIQ) Contract-Level Program Management support and Task Order-level Project Management support to establish control, staffing management, monitoring, and notification mechanisms and shall work with the Government Contracting Officer (CO), Contracting Officer’s Representative (COR) and subject matter experts (SMEs) to ensure that all tasks stay on track and important milestones are met.

The Contactor shall ensure management resources are in place to effectively plan and manage multiple Task Orders, and transition-on and -off activities, when required. The Contractor shall conduct transition activities, as needed, as Task Orders begin/end and as staff changes on an effort.

Staffing management activities shall include administrative and programmatic responsibilities to assist its applicable proposed Contractor personnel with completion of VISA documentation and H1B sponsorship and processing fees.

Specific task management and reporting activities will be detailed at the Task Order level.

The Contractor shall provide both Indefinite Delivery, Indefinite Quantity (IDIQ) Contract-Level Program Management support and Task Order-level Project Management support to establish control, management, monitoring, and notification mechanisms and shall work with the Government Contracting Officer (CO), Contracting Officer’s Representative (COR) and subject matter experts (SMEs) to ensure that all tasks stay on track and important milestones are met.

Representative activities include but are not limited to:

Meetings

The Contractor shall participate in various meetings for the IDIQ contract and, as required, for each Task Order. If Task Order requires meetings , the Contractor shall prepare the following:

meeting agenda, minutes or notes, issues and action items. Additionally, the Contractor may be required to distribute the related documentation (generally by email), and actively contribute to the meetings.

At a minimum, the Contractor shall convene and participate in the following meetings relating to the overall IDIQ contract:

• Contract Kickoff Meeting – Contractor will coordinate this meeting within 15 working days of contract award. Purpose of this meeting is to introduce Contractor staff to the government staff that will be managing the contract. Additionally, Contractor will begin work with the COR (and, if necessary, the CO) to determine the course of future status update meetings and the government’s expectations for reporting.

• Annual Update Meetings – Contractor shall coordinate quarterly meetings with responsible government staff (COR, and if necessary, CO) for the purpose of reporting the status of the overall contract and the individual Task Orders. During these meetings, Contractor shall report on costs and burn rates, schedule, demonstrations, presentations, transitions activities, site visits and any other factors which may impact Task Orders or the overall contract.

Staff Training and Management

• The Contractor shall support and verify that all personnel including new hires have the education, experience and training necessary to perform their duties and successful performance of contract requirements in terms of protocols for data-entry, quality control and various standardized coding technology

• The Contractor shall schedule, participate in and track required mandatory FDA training

• As appropriate to the size and scope of each Task Order, the Contractor shall develop, implement, and update a Management Plan to include communication plan, quality control plan, quality assurance plan, training plan, contingency plan, IT security plan and staffing plan o The Contractor shall provide management personnel for the administration and oversight of all phases of TOs and IDIQ contract o The Contractor shall provide a Management Plan to be developed in terms of technical approach, organizational resources and management control o The Contractor shall plan, organize, secure and manage resources with appropriate knowledge and skills o The Contractor shall manage Contractor staff and provide subcontractor management

• The Contractor shall safeguard all FDA confidential information

The Contractor shall NOT:

• Discuss with unauthorized persons any information obtained in the performance of work under this contract

• Conduct business not directly related to this contract on Government premises

• Use computer systems and/or other Government facilities for company or personal business other than work related to this contract

• Recruit on Government premises or otherwise act to disrupt official Government business

Process and Procedure Improvement

As required at each Task Order level, he Contractor shall provide ongoing reviews of existing processes and procedures to identify areas where improvements can be made as well as recommend changes that will benefit the quality, efficiency and/or effectiveness of the FDA’s standard operating procedures and business rules The Contractor shall research, plan, collect, analyze, recommend and implement changes to FDA processes and procedures, which may include for example: create and document processes and procedures according to organizational format templates, document as-is and to-be performance baselines, support the development and implementation of performance measures and surveillance methods.

Transition

The Contractor shall provide all management, administrative, clerical, and supervisory functions required for the effective and efficient performance of this contract. A smooth and orderly transition between the Contractor and the successor Contractor is necessary to ensure minimum disruption to vital Government business. The Contractor shall cooperate fully in the transition. At the IDIQ level, the Contractor will provide 30 days of transition to allocate this time to transition in activities and transition out activities. Such activities shall include meeting with the incoming vendor. The Contractor shall adhere to the same professional and ethical standards of conduct required of Government personnel. Specific transition-in and/or transition-out requirements may be provided in individual Task Orders. The Contractor shall provide transition activities as directed in each Task Order for beginning and ending efforts, as well as when staff transition on/off Task Orders in progress.

4. DELIVERABLES

Deliverables aligned with the task areas and service levels will be specified in each individual Task Order. The Contractor shall provide the designated Task Order COR with an electronic copy, in a file format specified by the COR, of each deliverable via physical media or via electronic mail (as specified by the COR) according to established deliverable schedule. The COR will review and provide comments back on deliverables within ten (10) workdays of receipt or as designated in the Task Order. The Contractor will have five (5) workdays to review and incorporate the COR’s comments and resubmit to the COR. This 10/5-day review cycle will repeat until Government’s acceptance of a deliverable. The Contractor shall provide all artifacts (e.g., scripts and software, including source code) developed to support this contract to the COR. These artifacts shall become the property of the Government.

5. OTHER REQUIREMENTS

Task Order Processing – All Task Orders issued hereunder are subject to the terms and conditions of the contract. The IDIQ contract takes precedence over the Task Order in the event of conflict with requirements and deliveries. Task Orders shall be “issued” for purposes of this contract upon the effective date of the order. The IDIQ contract COR must be notified when Task Orders are issued against the IDIQ, detailing Task Order number, scope, awarded amount, and pricing modifications. The anticipated single award IDIQ will allow for severable and non-severable services to be ordered on a Firm-Fixed Price, Time & Materials or Labor Hour basis.

Ordering under this contract shall be accomplished by the issuance of written Task Order. The only individual authorized to process Task Orders for the FDA, is an Office of Acquisitions & Grants Services (OAGS) Contracting Officer.

The general process for individual Task Orders is as follows:

a) The FDA will prepare a statement of work. The SOW will include, at a minimum, the following elements:

1. Task Order Number

2. Date

3. Accounting Information

4. SOW information:

i) Description of work in terms of the purpose or objectives of the work and location to be performed.

ii) Description of how the work performance is assessed relative to objectives, goals, and outcomes.

iii) Period and place of performance

iv) Reporting requirements and deliverables

v) Whether the order will be fixed price, labor hour, time and material or a hybrid type

Task Order.

vi) Deliverables

5. Price

6. TO Contracting Officer’s Representative

7. Any terms, conditions, or instructions, unique to the order.

b) Requests for Task Order Proposals (RFTOPs) shall only be issued by OAGS. All Task Orders issued under this contract shall conform to the provisions of Clause FAR. 52.216-18 “Ordering” in this contract.

The Contractor shall prepare and submit a Task Order proposal addressing all areas of the requirement. The Contractor shall submit the Task Order proposal within the time period specified in the RFTOP and adhere to the ceiling rates established in the contract. Other direct costs shall be clearly identified, explained, and substantiated. Travel Expenses - Travel rates will be limited to those costs authorized by the Federal Travel Regulations in effect at the time of TO negotiations.

Trips in excess of the approved number set forth in each TO will be at the Contractor’s expense.

The Contractor shall identify the estimated travel requirements by number, purpose, and duration (inclusive of travel days in/out) with the submission of each proposed TO. The government reserves the right to insert anticipated travel by utilizing Other Direct Costs (ODC). No separate payment will be made to the Contractor for the cost to prepare, submit and/or negotiate a Task Order proposal. The Government will evaluate Task Order proposals as specified in the individual

RFTOP.

It is the Government’s intention to perform closeout procedures on a Task Order basis as well as for the IDIQ Contract. The Contractor shall perform those internal functions necessary to support this process in a timely manner. The Task Order closeout will occur as soon as possible after required audit and establishment of final rates, as applicable.

6. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The following COR will represent the Government for the purpose of this IDIQ contract:

TBD

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

a) Performance of the work under this contract shall be subject to the technical direction of the

COR identified above, or a representative designated in writing. All questions regarding changes to the scope of work shall be directed to the Contracting Officer or Contracting Specialist. The term "technical direction" includes, without limitation, direction to the Contractor that directs or redirects the labor effort and shifts the work between work areas or locations to ensure that tasks outlined in the work statement are accomplished satisfactorily.

b) Technical direction must be within the scope of the specification(s)/work statement.

The COR does not have the authority to issue any technical direction that:

1. Constitutes a change of assignment of additional work outside the specification(s) / SOW

2. Constitutes a change as defined in the contract clause entitled “Changes”;

3. In any manner causes an increase or decrease in the total contract price, or the time required for contract performance;

4. Changes any of the terms, conditions, or specification(s)/work statement of the contract;

5. Interferes with the Contractor’s right to perform under the terms and conditions of the contract; or

6. Directs, supervises or otherwise controls the actions of the Contractor’s employees.

c) Technical directions may be oral or in writing. The COR shall confirm oral direction in writing within five workdays, with a copy to the CO.

d) The Contractor shall proceed promptly with the performance resulting from the technical directions issued by the COR. If, in the opinion of the Contractor, any direction of the COR, or his/her designee, falls within the limitations in (b), above, the Contractor shall immediately notify the CO no later than the beginning of the next Government workday

e) Failure of the Contractor and the CO to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause entitled "Disputes."

The type of actions within the purview of the COR’s authority is to assure that the Contractor performs the technical requirements of the contract, and to notify both the Contractor and the CO of any deficiencies observed.

7. CONTRACTING OFFICER (CO)

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in a Task Order; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

Contracting Officer (CO):

TBD

Phone Number Email

Contract Specialist (CS):

TBD

Phone Number Email

8. HOURS OF OPERATION

Meetings with the FDA shall be performed during normal work hours: Monday to Friday, 8:30 A.M. to 5:00 P.M. Eastern Time. There may be infrequent times when after hours or weekend support is needed (e.g., production deployments must occur after 9:00 PM Eastern Time). Such after hours or weekend requirements will be detailed in any Task Order to which it applies.

Observance of Federal Holidays – Government personnel observe the following days as holidays:

New Year’s Day Martin Luther King’s Birthday President’s Day Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day

Christmas Day

Government Closures – When the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closing, for other than firm fixed prices contract, the Contractor will not be reimbursed when the Government facility is closed for the above reasons. For unscheduled closing, (e.g., weather emergencies, Executive Orders, etc.) the Contractor shall seek guidance from the COR.

On the days that the Government is closed, the Contractor shall not work on-site at FDA facilities.

With COR prior approval and the proper equipment/network connectivity, the Contractor may be allowed to work remotely or from their facilities.

9. PERIOD OF PERFORMANCE

The estimated period of performance for this IDIQ contract shall consist of a five-year ordering period.

Period 1: January 30, 2023 to January 29, 2024 Period 2: January 30, 2024 to January 29, 2025 Period 3: January 30, 2025 to January 29, 2026 Period 4: January 30, 2026 to January 29, 2027 Period 5: January 30, 2027 to January 29, 2028

10. PLACE OF PERFORMANCE

The Contractor shall perform all work under this contract at FDA locations or as otherwise specified in individual Task Orders.

11. GOVERNMENT FURNISHED EQUIPMENT (GPE)/ GOVERNMENT FURNISHED

INFORMATION (GPI)

Each Task Order will identify Government Furnished Equipment and Government Furnished Information.

12. KEY PERSONNEL

The Key Personnel specified in Task Order(s) are considered to be essential to work performance.

At least 30 days prior to Contractor voluntarily diverting any of the specified individuals to other programs or contracts, the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement’s skills, experience, and credentials meet or exceed the requirement of the Task Order (including when applicable Human Subjects Testing requirements). If the employee of the Contractor is terminated for cause or separates from the from the Contractor voluntarily with less than 30 days’ notice, the Contractor shall provide the maximum notice practical under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without written consent of the Contracting Officer. The Task Order will be modified to add or delete key personnel as necessary to reflect the agreements to the parties.

Key Personnel, if so designated, will be detailed per each Task Order.

13. INVOICE SUBMISSION

HHSAR 352.232-71, ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(a ) Definitions. As used in this clause-

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract.

(b ) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c ) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d ) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(END OF CLAUSE)

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022) http://www.ipp.gov/ a . All Invoice submissions for goods and or services must be made electronically through the U.S.

Depa rtment of Treasury's Invoice Processing Platform System (IPP).

http://www.ipp.gov/vendors/index.htm b . Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the a pplicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1 . The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration ema il instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registra tion email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract a ward for new contracts or date of modification for existing contracts.

2 . Registra tion emails are sent via email from ipp.noreply@mail.eroc.twai.gov.

Contractor a ssistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3 . The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4 . If your company is already registered to use IPP, youwill not be required to re-register.

5 . If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov d . Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e . Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

• Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

• Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

• Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

• Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

• Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

• Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f . Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconcilia tion purposes:

(a) ) list of all invoices submitted to date under the subject a ward, including the following:

(1 ) invoice number, amount, & date submitted (2 ) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Pa yment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h . If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j . The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k . Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource a nd Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807- ERIC (3742); or, by email a t ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When ema iling, plea se be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

14. CONTRACTOR PERFORMANCE ASSESSMENT REPORT

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final Contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer’s discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final Contractor performance evaluations. CPARS is a secure Internet website located at https://www.cpars.gov/. FDA will register the Contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the Contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 14 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 14 days from date the evaluation was issued by the FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and Contractor responses, if any, will be retained as part of mailto:ERIC@fda.hhs.gov http://www.cpars.gov/ the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3-year period in the CPARS system.

Contractors may obtain CPARS training material and register for on-line training at https://www.cpars.gov/webtrain.htm. There is no fee for registration or use of the CPARS.

15. SECURITY REQUIREMENTS

Additional security requirements may be stipulated in each Task Order using applicable sections of the “FDA Security and Privacy Language for Information and Information Technology Procurements” document.

16. SUPPORT FOR CAPITAL PLANNING AND INVESTMENT CONTROL

The FDA is required to manage and produce reports to HHS and other federal agencies. The Contractor shall respond to FDA data calls, requests for input and ad hoc support necessary for FDA to comply with Capital Planning and Investment Control (CPIC), OMB Circular A-11 requirements for FDA systems, enterprise architecture and strategic planning which occur in differing reporting cycles. The Contractor shall support and provide data required by FDA to manage the FDA Investment Portfolio and develop operating procedures for presentation to the governance boards in accordance with the standards required by the Clinger-Cohen Act.

17. CLAUSES

FEDERAL ACQUISITION REGULATION CLAUSES

52.252‐2 ‐‐ Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): http://farsite.hill.af.mil/ 52.217-8 Option to Extend Services (Nov 1999) 52.227-14 Rights in Data – General (May 2014)

HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) CLAUSES

HHSAR CLAUSES INCORPORATED BY REFERENCE

Full text versions can be viewed at: http://www.hhs.gov/regulations/hhsar/subpart352.html 352.237‐75 – Key Personnel (DEC 2015)

352.239‐74 – Electronic and Information Technology Accessibility (December 18, 2015) http://www.cpars.gov/webtrain.htm http://farsite.hill.af.mil/ http://www.hhs.gov/regulations/hhsar/subpart352.html

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access‐board.gov/guidelines‐and‐standards/communications‐and‐it/about‐the‐ section‐508‐standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The Contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are:

1. Must meet WCAG 2.0 A and AA

2. E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

3. E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

4. E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

5. E205 Electronic Content (Appendix A, Application and Scoping Requirements)

6. 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and

Technical Requirements)

7. Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html.

Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative

8. E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

9. Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the Contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website: (http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and http://www.hhs.gov/web/508 http://www.access/ http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html http://www.hhs.gov/web/508 services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

A. Baseline Security Requirements

Applicability. The requirements herein apply whether the entire contract or order (hereafter “contract”), or portion thereof, includes either or both of the following:

Access (Physical or Logical) to Government Information: A Contractor (and/or any subContractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

Operate a Federal System Containing Information: A Contractor (and/or any subContractor) will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

Safeguarding Information and Information Systems. In accordance with the Federal Information

Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subContractor) shall:

Protect government information and information systems in order to ensure:

• Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

• Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

• Availability, which means ensuring timely and reliable access to and use of information.

http://www.hhs.gov/web/508

Provide security for any Contractor systems, and information contained therein, connected to an FDA network or operated by the Contractor on behalf of FDA regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party. This includes notifying the FDA Systems Management Center (SMC) within one (1) hour of discovery/detection in the event of an information security incident.

Adopt and implement the policies, procedures, controls, and standards required by the HHS/FDA Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the FDA Information Security Program security requirements, outlined in the FDA Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing your ISSO.

Comply with the Privacy Act requirements and tailor FAR clauses as needed.

Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Confidentiality: [ ] Low [ X ] Moderate [ ] High Integrity: [ ] Low [ X ] Moderate [ ] High Availability: [ ] Low [ X ] Moderate [ ] High Overall Risk Level: [ ] Low [ X ] Moderate [ ] High

Based on information provided by the Privacy Office, system/data owner, or other privacy representative, it has been determined that this solicitation/contract involves:

[ ] No PII [ X ] Yes PII

Personally Identifiable Information (PII). Per the OMB Circular A-130, “PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual.” Examples of PII include, but are not limited to the following: Social Security number, date and place of birth, mother’s maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be: [ ] Low [X ] Moderate [ ] High

Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf information.” The Contractor (and/or any subContractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R.

2002.4(aa). As implemented the term “handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re- using, and disposing of the information.” 81 Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

b. disclosed to authorized personnel on a Need-To-Know basis;

c. protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

d. returned to FDA control, destroyed when no longer needed, or held until otherwise directed.

Destruction of information and/or data shall be accomplished in accordance with NIST SP 800- 88, Guidelines for Media Sanitization and the FDA IS2P Appendix T: Sanitization of Computer- Related Storage Media.

Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

Confidentiality and Nondisclosure of Information. Any information provided to the Contractor (and/or any subcontractor) by FDA or collected by the Contractor on behalf of FDA shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor.